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Ajulia Executive Search

Senior Analytical Chemist

Post Date:Feb 19, 2021Type:Full-Time
Start Date:2/19/2021Salary:
Location:US-NJ-Edison Job Reference:52
Skills:
 

Job Description:

Senior Analytical Chemist - Research & Development

Responsible for:

            - Conduct analytical method development, method validation/verification, method                         transfer, stability studies, analytical testing in support of drug product development.

            - Write method validation/verification protocols, reports, release specifications, test                      methods, test reports, CoAs, SOPs and prepare CMC required documentation in                  support of ANDA submission, per necessary.

            - Work as Analytical Project Leaders on cross function teams such as Formulation group,                              Manufacturing Group, Quality Assurance, Quality Control, and interface with                               internal/external clients to meet required project timeline.

            - Maintain laboratory equipment log, calibration log, inventory supplies, safety records,                training records, notebooks, and all related documentation in compliance with the                         company SOPs, EHS standards, compendia and cGMP/GLP requirements.                                 Attend/conduct in house training sessions as per to functions.

            -  Perform data review of cGMP/GLP analytical testing on raw materials, intermediates,                              finished products, stability testing, validation reports, qualification data per necessary.

Requirements:

            - MS/BS in Analytical Chemistry, Pharmaceutics, or related field.

            - MS with 5+ years or BS with 7+ years of experience in Analytical method development                and validation in the pharmaceutical industry.

            -  Familiar with modern analytical instrumentation including HPLC, GC, KarlFisher,                           UV/VIS, FTIR, Dissolution testing.

            - Knowledge of cGMP /GLP and compendia guidelines.

            - Proficient in Microsoft Office toolkits and be able to write test methods, protocols, and                reports.





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Ajulia Executive Search



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